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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K232432
Device Name E3D™-A Interbody System
Applicant
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Applicant Contact Todd Wallenstein
Correspondent
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Correspondent Contact Todd Wallenstein
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   PHM  
Date Received08/11/2023
Decision Date 01/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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